There is a novel development in the world of Balloon Sinuplasty. Traditionally we utilize fluoroscopy (real time x-ray) to guide the wire into the sinuses, however, Acclarent has recently developed a fiberoptic light wire to allow the surgeon to transilluminate the sinus. This may eliminate the need for radiation exposure and potentially bring some of these sinus procedures into the clinic. This potentially could represent a significant advancement in recalcitrant sinus disease.
The Balloon Sinuplasty TM System
Using endoscopic techniques, the Balloon Sinuplasty TM system enables qualified otolaryngologists to dilate obstructed sinus ostia in patients suffering from sinusitis. The system is based on flexible catheter and wire technology specifically designed to navigate the tortuous sinus anatomy with minimal trauma. All products have been cleared by the U.S. Food and Drug Administration.
Relieva Luma ™ Sinus Illumination System & Accessories
The Relieva Luma Sinus Illumination System presents an innovative new option for confirming sinus access for ostial dilation. Harnessing unique trans-sinus illumination technology, Relieva Luma delivers a remarkable combination of full-strength, targeted fiberoptic light transmission and agile device handling. Relieva Luma is compatible with all existing Relieva® products.
Sinusitis affects 37 million people each year, making it one of the most common health problems in the U.S. It is more prevalent than arthritis and hypertension and has a greater impact on quality of life than diabetes or congestive heart failure. Sinusitis is also responsible for $8 billion* in direct healthcare expenditures and a significant loss of workplace productivity.1
Sinusitis is defined as an inflammation of the sinus lining commonly caused by bacterial, viral and / or microbial infections; as well as, structural issues such as ostial blockage. Symptoms include nasal congestion, facial discomfort, nasal discharge, headache, and fatigue. Sinusitis is considered acute when symptoms last 4 weeks or less. The disease is considered chronic when it lasts 3 months or longer.
The most frequently used treatments are medications and / or Functional Endoscopic Sinus Surgery (FESS). Treatment with antibiotics or topical nasal steroid spray is often successful in reducing mucosal swelling and relieving obstructions within the sinus ostium and ostio-meatal region. However, an estimated 20-25% of patients do not respond adequately to medications.2
For these patients, surgery is often their next step toward finding relief. The goals of sinus surgery are to clear blocked sinuses, restore normal sinus drainage and function, while preserving normal anatomy and mucosal tissue. Currently with FESS, specialized probes are used to cannulate closed ostia, and small forceps are used to resect periostial bone and tissue to enlarge the sinus ostia. Removal of bone and tissue may lead to post-operative pain, scarring, and bleeding. Nasal packing may be required to control the bleeding. Annually approximately 330,000 FESS procedures are performed with an 80-90% success rate in relieving symptoms.3
A significant unmet clinical need
With no desirable treatment, over 600,000 patients are left living with their sinus condition.4 These patients may not find adequate relief from medical therapy and are candidates for surgery, but for a variety of clinical or personal reasons choose not to undergo FESS using existing surgical instruments.
Balloon Sinuplasty TM Technology: Novel, endoscopic, catheter-based devices
Balloon Sinuplasty TM products are endoscopic, catheter-based devices used to dilate blocked paranasal sinus ostia. These devices are endoscopic tools and may be used with other medical therapies or FESS techniques. To read more about the Balloon Sinuplasty TM technology, visit their website.